FDA Delayed Enforcement of DQSA Requirements – Part II

By David Lennard, Vice President and Ellyn McMullin, Research Associate, Axendia

Delayed Enforcement Provides Opportunity to Develop Complimentary Systems

The FDA’s delayed enforcement of DQSA requirements until May 1, 2015 and its second enforcement delay for dispensers until November 1, 2015, may be an unexpected “gift” that gives some companies not only more time to implement data sharing agreements but also the opportunity to reap the business rewards of data mapping and visibility into their own supply chain at the same time.

In the initial article in this series, we discussed how organizations can use DQSA data to benefit their business and their relationships with trading partners.

In this article we cover a key provision of DQSA:  the identification, control and handling of suspect and illegitimate product. 

This is really the heart of the new regulation. Trading partners across the supplier network must develop processes to quickly investigate and remove illegitimate product from the market place.

The regulation provides the following definitions for Suspect and Illegitimate Product:

  •  Suspect Product – a product for which there is reason to believe that it:

(A) is potentially counterfeit, diverted, or stolen;

(B) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(C) is potentially the subject of a fraudulent transaction;  or

(D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

  • Illegitimate Product – a product for which credible evidence exists showing that the product IS any of the above.

The handling of suspect and illegitimate product could potentially become a logistical nightmare in both the processing and notifications required across a company’s supply network.  The FDA recognized the potential disruptions of prescription drugs in the supply chain due to the short notice of the final guidance document and originally gave the industry a 5 month reprieve only for the enforcement of the capturing and documenting of product tracing information among trading partners. The recent guidance extends the compliance deadline for dispensers until November 1, 2015.

With the new delay in the enforcement of the regulation you now have additional time to reevaluate systems and processes with your trading partners to develop more effective solutions that will not only improve efficiency but also provide better visibility to management.

Critical Elements that your system needs to include:critical

  • The ability to respond to a request for information about suspect or illegitimate product within 1 business day of a request by Federal or State agencies
  • The processes to quarantine suspect product across all business partners
  • The means to promptly conduct investigations in coordination with trading partners, as applicable
  • The channels to notify regulators and all immediate trading partners within 24 hours that a product was found to be illegitimate
  • The procedures to handle cleared product that proves not to be illegitimate and could be reintroduced into the distribution chain.


The handling of Suspect and Illegitimate Product under the Drug Supply Chain Security Act (DSCSA) involves many trading partners who now, for the first time, must think like a Pharmaceutical or Bio-tech company in terms of product investigations and controls.

We believe it is vital to develop complimentary systems to facilitate this on-going back and forth exchange of information and investigations.  There are many technology system solutions (versus paper or homegrown solutions) available that should be seriously considered.  Not only will such systems, when implemented, provide a common platform for trading partners to communicate but also will provide the backbone for implementation of the many phases of DSCSA to be put into effect over the next 10 years.

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